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Fecobionics Device for Chronic Constipation

N/A

Recruiting

Led By Hans Gregersen, MD

Research Sponsored by University of California, San Diego

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Constipation patients: Rome IV diagnostic criteria will be used to diagnose chronic constipation. Patients must have experienced at least two of the following symptoms over the preceding 3 months: Fewer than three spontaneous bowel movements per week, Straining for more than 25% of defecation attempts, Lumpy or hard stools for at least 25% of defecation attempts, and sensation of anorectal obstruction or blockage.

Normal subjects: Normal defecation pattern, i.e., bowel movement once every day or other day without excessive straining and sense of complete evacuation.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 4 years

Awards & highlights

Study Summary

This trial is testing a new device that may help to understand and treat chronic constipation. The device, called Fecobionics, is a simulated stool that records pressure, cross-sectional area, orientation, bending, and shape of the rectum and anal canal simultaneously. The goal is to study the defecation dynamics in normal control subjects and compare them to patients with chronic constipation to see if abnormalities of rectal contraction contribute to the condition.

Who is the study for?

This trial is for adults with normal bowel movements or those meeting the Rome IV criteria for chronic constipation, which includes symptoms like infrequent bowel movements and difficulty during defecation. Excluded are pregnant women, individuals unwilling to consent to tests, those with fecal incontinence, significant chronic diseases, medication affecting anorectal function, or a history of relevant surgeries.Check my eligibility

What is being tested?

The study is testing how well a new device called Fecobionics can mimic and measure the natural process of defecation by recording various parameters in both healthy subjects and patients with chronic constipation. It aims to improve understanding of normal and abnormal defecatory patterns without using invasive methods or radiation.See study design

What are the potential side effects?

As this trial involves a diagnostic device rather than medication, traditional side effects associated with drugs may not apply. However, participants might experience discomfort or minor pain related to the insertion of the Fecobionics device.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have chronic constipation based on specific symptoms I've had for the last 3 months.

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I have regular bowel movements without difficulty.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 4 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~4 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Evacuation duration of rectal balloon.

Secondary outcome measures

Anorectal angle.

Rectal contraction pressure.

Side effects data

From undefined Phase 3 trial • 368 Patients • NCT00526097

53%

Diarrhoea

25%

Abdominal pain

Abdominal pain upper

Headache

100%

80%

60%

40%

20%

Study treatment Arm

Bisacodyl

Placebo

Trial Design

2Treatment groups

Experimental Treatment

Group I: Effect of bisacodyl on the defecationExperimental Treatment1 Intervention

Bisacodyl is a stimulant of rectal contraction and expected to facilitate evacuation of rectal balloon (fecobionics device). Each subject will be studied twice, once with and once without bisacodyl.

Group II: Effect of atropine on the defecationExperimental Treatment1 Intervention

Atropine is an anticholinergic drug and expected to inhibit rectal contractions and inhibit evacuation of the rectal balloon. Each subject will be studied twice once with and once without atropine.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Bisacodyl

2008

Completed Phase 4

~3050

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of California, San DiegoLead Sponsor

1,121 Previous Clinical Trials

1,521,295 Total Patients Enrolled

Hans Gregersen, MDPrincipal InvestigatorCalifornia Medical Innovations Institute

Media Library

Atropin Clinical Trial Eligibility Overview. Trial Name: NCT04903470 — N/A

Constipation Research Study Groups: Effect of atropine on the defecation, Effect of bisacodyl on the defecation

Constipation Clinical Trial 2023: Atropin Highlights & Side Effects. Trial Name: NCT04903470 — N/A

Atropin 2023 Treatment Timeline for Medical Study. Trial Name: NCT04903470 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the total population of participants in this research project?

"Affirmative. Clinicaltrials.gov demonstrates that the recruitment process for this trial has been ongoing since June 15th 2021, with its most recent update occurring on July 28 2022. 130 applicants must be accepted at a single medical centre to fulfil requirements of the study."

Answered by AI

Is this medical investigation currently open for enrollment?

"Affirmative. Information hosted on clinicaltrials.gov suggests that this medical experiment, which was launched on June 15th 2021, is currently enrolling participants. Notably, the researchers need to recruit 130 individuals from one study site."

Answered by AI

Might I be a suitable candidate to join this medical research?

"The criteria for being accepted into this clinical trial entails having dyschezia and falling between the ages of 21 to 75. The team is looking to recruit a total of 130 participants."

Answered by AI

Does this research endeavor include participants over the age of three-quarters of a century?

"Potential participants must be between 21 and 75 years old to qualify for this trial."

Answered by AI

Has there been any additional research conducted involving Atropin?

"Currently, there are 24 active trials for Atropin, with 7 of them in their final stage. These studies span 156 different centres across the world, with a significant concentration located in Shanghai."

Answered by AI

In what circumstances is Atropin usually prescribed?

"Atropin is frequently implemented to treat excessive laughing, however it may also aid in the remediation of rhinorrhoea, pupil dilation and intestinal discomfort."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Defecation Patterns in Constipated Patients

Ravinder Mittal 2021. "Defecation Patterns in Constipated Patients". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04903470.

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